(65 days)
The Vector™ PTA Balloon Dilatation Catheter is recommended for Percutaneous Transluminal Angioplasty (PTA) of the femoral, iliac, popliteal, and renal arteries and for the treatment of obstructive lesions of native or synthetic arterio-venous dialysis fistulae.
The Vector" Catheter is not indicated for use in the coronary arteries or for placement of or post dilatation of stents.
The Vector™ PTA Balloon Dilatation Catheter is a high pressure, non-compliant balloon catheter. It is a coaxial dual lumen over-the-wire balloon dilatation catheter. The central lumen accommodates guide wires up to the 0.035 inches in diameter while the outer lumen is the inflation lumen for the balloon.
The balloon is a high pressure composite balloon with radio-opaque marker bands to help visualize the balloon placement within the vasculature during both placement and inflation. The balloon's rated burst pressure is 30 atm.
The provided document is a 510(k) summary for a medical device called the Vector™ PTA Balloon Dilatation Catheter (K143652). It outlines the device's technical characteristics, intended use, and a summary of performance testing to establish substantial equivalence to a predicate device.
Here's an analysis to extract the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria / Performance Specification | Reported Device Performance |
|---|---|
| Rated Burst Pressure | Met specifications |
| Balloon Compliance | Met specifications |
| Balloon Diameter Sizing | Met specifications |
| Inflation/Deflation Times | Met specifications |
| Repeat Inflation | Met specifications |
| Removal/Refold & Reuse | Met specifications |
| Flexibility / Kink | Met specifications |
| Crossing Profile | Met specifications |
| Balloon Protector Removal | Met specifications |
| Guidewire/Introducer Compatibility | Met specifications |
| Tensile Strength | Met specifications |
| Visibility under Fluoro-imaging | Met specifications |
| Torque Strength | Met specifications |
| Catheter Leak | Met specifications |
| Sterilization (SAL 10-6) | Achieved via Ethylene Oxide |
| Biocompatibility (ISO 10993-1) | Met requirements |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes used for each individual test. It mentions "All devices met the performance specifications" implying that a sufficient number of devices were tested for each performance characteristic. The data provenance is not specified, but the testing would typically be internal bench testing conducted by the manufacturer. It is not a clinical study, so concepts like country of origin or retrospective/prospective don't apply in the same way.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This document describes bench testing of a device's physical and functional properties, not a diagnostic or AI device that relies on expert interpretation to establish "ground truth." Therefore, this question is not applicable. The "ground truth" for these tests are the engineering specifications and established test methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable as the document describes bench testing of a physical device, not an assessment requiring expert adjudication of clinical outcomes or diagnostic interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable. This is a 510(k) submission for a physical medical device (balloon catheter), not an AI/CAD diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance tests described (Rated Burst Pressure, Balloon Compliance, etc.), the "ground truth" is defined by the engineering specifications, industry standards, and established test methodologies. For example, the rated burst pressure is a design specification that the device must meet or exceed. There is no expert consensus, pathology, or outcomes data involved in establishing "ground truth" for these types of bench tests.
8. The sample size for the training set
This question is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This question is not applicable. As there is no training set, there is no ground truth for it.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).